Dose Calculator

K150848 · Sun Nuclear Corporation · IYE · May 20, 2015 · Radiology

Device Facts

• Record ID: K150848
• Device Name: Dose Calculator
• Applicant: Sun Nuclear Corporation
• Product Code: IYE · Radiology
• Decision Date: May 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Sun Nuclear Dose Calculator is a software product intended to compute a radiotherapy dose volume.

Device Story

Software module for secondary check QA in external beam photon radiation therapy; computes radiotherapy dose volumes. Inputs: 3D volumetric imaging (e.g., CT) and beam intensity values in DICOM-RT format. Operation: utilizes provided beam model for specific treatment delivery device to calculate dose. Output: DICOM-RT dose volume. Used in clinical settings by medical physicists/dosimetrists to verify treatment plans. Benefits: provides independent dose calculation to ensure accuracy of radiation delivery; supports clinical decision-making by confirming treatment plan validity before patient exposure.

Clinical Evidence

Bench testing only. No clinical data provided. Testing demonstrated device performance within design specifications and equivalence to the predicate device.

Technological Characteristics

Software-based secondary check QA tool. Inputs/outputs: DICOM-RT format. Computes dose volumes using 3D volumetric imaging and beam intensity values. Operates as a software module for Sun Nuclear or third-party applications. No hardware components.

Indications for Use

Indicated for use in external beam photon radiation therapy to compute radiotherapy dose volumes. Not indicated for charged particle radiotherapy calculations, including electron, proton, and heavy ion therapy.

Regulatory Classification

Identification

A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

Predicate Devices

• Mobius 3D (K140660)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2015

Sun Nuclear Corporation % Mr. James Luker Regulatory Affairs Manager 3275 Suntree Boulevard MELBOURNE FL 32940

Re: K150848

Trade/Device Name: Model 1218028 Dose Calculator Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: March 13, 2015 Received: March 31, 2015

Dear Mr. Luker:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael O'Hara

For

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use Form

# 510(k) Number (if known): _ K150848

### Device Name: Model 1218028 Dose Calculator

### Indications for Use:

The Sun Nuclear Dose Calculator is a software product intended to compute a radiotherapy dose volume.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over-The-Counter Use (21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

K150848 510(k)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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Image /page/3/Picture/0 description: The image shows the logo for Sun Nuclear Corporation. The logo consists of a blue square with a yellow sun inside on the left, and the words "SUN NUCLEAR" in blue on the right. Below the words "SUN NUCLEAR" is the word "corporation" in a smaller blue font.

# Section 5 - 510(k) Summary

Provided in accordance with 21 CFR 807.92 (c)

#### 1 General Provisions

Date Prepared:

March 12, 2015

Submitted by:

Sun Nuclear Corporation 3275 Suntree Blvd. Melbourne, FL 32940 Ph: 321-259-6862 Fax: [phone] Web: www.sunnuclear.com

Contact Person:

James Luker [e-mail]

Ph: 321-259-6862 extension 2428

Classification Name:

Accelerator, Linear, Medical

Common Name:

Secondary check QA software

Proprietary Names:

Model 1218028 Dose Calculator

Establishment Registration Number:

1038814

Classification:

Regulation Number: 21 CFR 892.5050 Name: Accelerator, Linear, Medical Product code: IYE

Class II

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Predicate Device(s):

| Model Name: | Mobius 3D |
|---------------|-----------------------------|
| Common Name: | Secondary check QA software |
| 510(k) # | K140660 |
| Manufacturer: | Mobius Medical Systems, LP |
| Submitted: | May 05, 2014 |

To our knowledge, this predicate has not been subject to a designrelated recall.

#### 2 Description and Use:

Model 1218028 Dose Calculator computes a dose volume for a user-specified treatment delivery device based on user-provided three dimensional volumetric imaging information (e.g., computed tomography) and beam intensity values. Both the imaging data and beam intensity values are specified in DICOM-RT format. The beam model for the specified treatment delivery device is provided with the software. The output of the SDC is a DICOM RT dose volume.

The Dose Calculator is for use with external beam photon radiation therapy calculations. Charged particle radiotherapy calculations (including electron, proton, and heavy ion therapy) are not indicated for use with this product.

The Dose Calculator software application is considered to be a software module that may be used by several Sun Nuclear Corporation products and/or 300 party applications.

#### 3 Intended Use Statement:

The Sun Nuclear Dose Calculator is a software product intended to compute a radiotherapy dose volume.

#### ব Technological Characteristics

The primary technological characteristics of the Model 1218028 Dose Calculator are the usage of three dimensional volumetric imaging information and beam intensity values in DICOM-RT format to compute a dose volume (also in DICOM-RT format). The technological characteristics are believed to be substantially equivalent to the predicate device.

#### 5 Performance Data and Comparison with Predicate

Model 1218028 Dose Calculator has been tested using appropriate bench testing methods. Test results of the modified device have demonstrated that the device performs within its design specifications and equivalently to the predicate device.

#### 6 Summarv

Model 1218028 Dose Calculator is believed to be substantially equivalent to the predicate Mobius 3D device due to the similarities in function, technology, and performance. The intended use, performance testing, safety and effectiveness reviews demonstrate that Model 1218028 Dose Calculator is as safe, as effective, and performs as well as the predicate device.